Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus (DM) on Combination Oral Therapy

NCT01060241 | Suspended

• 1 other identifier: T2D Combination-Internet BGM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This project will test the effectiveness of an Internet based glucose monitoring system on the A1C levels of patients with type 2 diabetes. All of the patients are given a meter and test strips to test their blood glucose levels, however, half of them will be required to also upload their meter onto the Internet which can then be viewed by their endocrinologist. The doctor can then send a message back to the patient and comment on the readings. The effect of the ongoing communication will be measured by the changes in the glucose levels (HbA1C) over 3 and 6 months.

Conditions

Type 2 Diabetes Mellitus

Keywords

Remote Blood Glucose Monitoring System, Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the A1c level or the change in A1c level

  6 Months

Secondary Outcomes (1)

• The secondary endpoints include severe hypoglycemia defined as requiring external aid, hospital admissions for any CVD related intervention, and adverse events such as unplanned hospitalizations for any cause that last more than 24 hours

  6 Months

Study Arms (2)

Internet Intervention

EXPERIMENTAL

The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.

Other: Internet Intervention

Standard Care

NO INTERVENTION

This arm will receive standard care which includes self-blood glucose monitoring at least 3 times daily and visit to the endocrinologist at least once every 3 months.

Interventions

Internet Intervention OTHER

The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.

Also known as: Remote Blood Glucose Monitoring System

Internet Intervention

Eligibility Criteria

• Age: 25 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes patients treated with 2 or more oral anti-diabetic medication
• A1C \>7%
• \>25 years of age
• Willingness to test blood glucose levels a minimum of 3 times daily
• Willingness to be randomized
• Trained in self blood glucose monitoring
• Internet Access

You may not qualify if:

• In addition patients with the potential to become pregnant or patients using medications known to influence control of diabetes (eg steroids systemic or inhaled) are excluded from the study.

Sponsors & Collaborators

• Endocrine Research Society: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (4)

• Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.

  PMID: 16371630 BACKGROUND

• Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.

  PMID: 9742976 BACKGROUND

• Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008 Dec;10(6):419-39. doi: 10.1089/dia.2008.0104.

  PMID: 18937550 BACKGROUND

• Klonoff DC, Bergenstal R, Blonde L, Boren SA, Church TS, Gaffaney J, Jovanovic L, Kendall DM, Kollman C, Kovatchev BP, Leippert C, Owens DR, Polonsky WH, Reach G, Renard E, Riddell MC, Rubin RR, Schnell O, Siminiero LM, Vigersky RA, Wilson DM, Wollitzer AO. Consensus report of the coalition for clinical research-self-monitoring of blood glucose. J Diabetes Sci Technol. 2008 Nov;2(6):1030-53. doi: 10.1177/193229680800200612.

  PMID: 19885292 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hugh D Tildesley, MD

  Providence Health Care, University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 2, 2010
• Study Start: February 1, 2010
• Last Updated: June 29, 2011

Record last verified: 2010-01

Locations

CA (1)